Impureza Betaxolol EP Impurity C (CAS 63659-17-6) | conhecida também como Betaxolol Oxirane Analog ou [[4-[2-(Cyclopropylmethoxy)ethyl]phenoxy]methyl]oxirane | é um subproduto oxirano identificado em lotes de betaxolol. A sua presença representa um marcador crítico de via sintética incompleta ou de reações secundárias envolvendo epoxidação. Do ponto de vista analítico | exige caracterização por HPLC acoplada à espectrometria de massas e confirmação estrutural por RMN para garantir identificação inequívoca. O controlo desta impureza é essencial para conformidade farmacopéica e avaliação de estabilidade | uma vez que pode influenciar perfil de segurança e eficácia do produto final.
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